Pilot Study of 1cm Versus 2cm Margins for the Surgical Treatment of cT2N0M0 Melanoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Malignant Melanoma
- Sponsor
- University of Kansas Medical Center
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Number of participants who agree to blinded randomization to a surgical margin trial for the treatment of early stage melanoma.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This is a randomized non-blinded pilot study for patients with melanoma staging cT2N0M0 who are candidates for surgical resection. The primary objective is to determine the feasibility of randomizing participants with cT2N0M0 malignant melanoma to surgical treatment with 1cm versus 2cm margins. Study will try to determine overall survival for cT2N0M0 malignant melanoma after surgical treatment with 1cm versus 2cm margins.
Detailed Description
After randomization, participants will undergo surgery with wide local excision with either 1cm or 2cm margins. The margin will be based upon the previous biopsy site or area of pigmentation. The skin and subcutaneous tissue (down to fascia) will be resected. Closure considerations may require removal of additional tissue for non-oncologic purposes. As per standard of care, sentinel lymph node biopsy will be performed using a dual tracer technique (technetium radiolabeled sulfur colloid and isosulfan blue) with or without lymphoscintigraphy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Biopsy proven T2 malignant melanoma.
- •Eastern Cooperative Oncology Group (ECOG) score of 0-2.
Exclusion Criteria
- •Visible additional disease that suggests a greater than T2 malignant melanoma
- •Unable to tolerate general anesthesia
- •Evidence of distant metastatic disease
- •Melanoma located on face or digits
Outcomes
Primary Outcomes
Number of participants who agree to blinded randomization to a surgical margin trial for the treatment of early stage melanoma.
Time Frame: 2 years
Number of patients who agree to participate
Secondary Outcomes
- Quality of life following surgery(One month post-surgery)
- Recurrence (disease free survival)(Every 4 months post-surgery for 2 years and then every 4-6 months for an additional 3 years)